Inuniv and Working Memory
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 12 |
| Updated: | 5/5/2014 |
| Start Date: | July 2010 |
| End Date: | September 2013 |
| Contact: | Lori A Schweickert, MD |
| Email: | schweickert@3cfs.com |
| Phone: | 919 677-0101 |
Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD
Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release
guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing
using a standardized battery of tests for effect on symptoms of ADHD and working memory will
be administered and assessed.
guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing
using a standardized battery of tests for effect on symptoms of ADHD and working memory will
be administered and assessed.
Inclusion Criteria:
1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype,
as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline
- 2 Outpatient status
- 3. Age 8-12 (inclusive) at baseline
- 4. Males or Pre-menarchal females
- 5. English-speaking parent and subject
- 6. If on stimulant medication, has demonstrated sub-optimal response to treatment ad
is willing to be washed out (discontinued) from stimulant
- 7. Intellectual capacity to provide assent, as deemed by the Principal Investigator
- 8. No known cardiac history, including bradycardia, heart block, syncope or
tachycardia
- 9. No known history of hypotension or hypotension at baseline
- 10. Willing to provide informed consent/ assent per IRB protocol
Exclusion Criteria:
- • 1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive
subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline
- 2 Outpatient status
- 3. Age 8-12 (inclusive) at baseline
- 4. Males or Pre-menarchal females
- 5. English-speaking parent and subject
- 6. If on stimulant medication, has demonstrated sub-optimal response to
treatment ad is willing to be washed out (discontinued) from stimulant
- 7. Intellectual capacity to provide assent, as deemed by the Principal
Investigator
- 8. No known cardiac history, including bradycardia, heart block, syncope or or
tachycardia
- 9. No known history of hypotension or hypotension at baseline
- 10. Willing to provide informed consent/ assent per IRB protocol 11. No history
of hepatic or renal impairment
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